Senior Clinical Research Associate
hace 1 semana
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.
What You'll Do:
- Serve as main CTI contact for assigned study sites
- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
- Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection
- Collect, review and track essential/regulatory documents
- Participate in and complete all general and study specific training as required
- Participate in investigator, client and project team meetings; may include presentations
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
- Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures
- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available
- Provide regular updates to Sponsor/ Client Where applicable, support or oversee contract negotiation with study sites, Investigator payments and tracking of site payments
- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans Identify and anticipate site issues and implement corrective and preventive actions or escalate as appropriate
- Liaise with Clinical Data Management for data cleaning activities
- Serve as mentor / trainer for CRAs; may include conducting training/assessment visits
- Function in the role of Lead CRA for assigned project(s)
- Identify and propose process improvements
- Provide therapeutic area expertise to team members
What You Bring:
- 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
- Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources
- Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO
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